Effectiveness of Virtual Multicomponent Treatment for Chronic Fatigue Syndrome: VIRTUAL SFCAMINA STUDY
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Fatigue Syndrome
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Enrollment
- 480
- Locations
- 1
- Primary Endpoint
- Multidimensional Fatigue Inventory (MFI)
- Last Updated
- 4 years ago
Overview
Brief Summary
The main objective of this study is to analyse the effectiveness of the VIRTUAL SFCAMINA multicomponent treatment program as coadjuvant of treatmentas- usual (TAU) compared to TAU alone. In this Randomized Controlled Trial (RCT), in addition to evaluating the clinical effects of VIRTUAL SFCAMINA treatment in the short- and long term.
Detailed Description
This is a tree-arm RCT focused on the safety and potential effectiveness of the multicomponent program VIRTUAL SFCAMINA as coadjuvant of treatmentas- usual (TAU) vs. TAU alone. * VIRTUAL SFCAMINA combines multicomponent approach based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness training. * The main hypothesis is that improvement on fatigue of patients with fibromyalgia can be achieved by the direct intervention on mechanisms such as kinesiophobia, fear avoidance and by individualized therapeutic exercise.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Meet the Fukuda and Holmes classification criteria for Fatigue Syndrome Chronicle
- •Age equal to or greater than 18 years
- •Understand and agree to participate in the study
- •Sign the informed consent
Exclusion Criteria
- •Terminal clinical conditions or scheduled treatments that may interrupt the study follow-up.
Outcomes
Primary Outcomes
Multidimensional Fatigue Inventory (MFI)
Time Frame: Through study completion, an average of 3 months
Multidimensional Fatigue Inventory (MFI), a 20-item instrument consisting of several subscales including general fatigue and reduced activity. Severe fatigue it is defined as a score of greater than or equal to 13 on the MFI general fatigue subscale or greater than or equal to 10 on the MFI reduced activity subscale. The mean MFI general fatigue scores ranged from 18.3 to 18.8
Secondary Outcomes
- Tampa Scale for Kinesiophobia (TSK-11)(Through study completion, an average of 3 months)
- Physical Function of the 36-Item Short Form Survey (SF-36)(Through study completion, an average of 3 months)
- Hospital Anxiety and Depression Scale (HADS)(Through study completion, an average of 3 months)